Undersøgelse for at lære mere om sikkerheden og effektiviteten af lægemidlet VITRAKVI under rutinemæssig brug hos patienter med TRK-fusionskræft, som er lokalt avanceret eller spredt fra det sted, hvor det startede, til andre steder i kroppen (ON-TRK)
Prospektiv ikke-interventionsundersøgelse i patienter med lokalt avanceret eller metastatisk TRK-fusionskræft behandlet med larotrectinib
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Kontakter og lokationer
Studiesteder
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Many Locations, Argentina
- Many Locations
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Many Locations, Belgien
- Many Locations
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Many Locations, Canada
- Many Locations
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Many Locations, Finland
- Many Locations
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California
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Los Angeles, California, Forenede Stater, 90095
- UCLA - Mattel Children's Hospital
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Los Angeles, California, Forenede Stater, 90027
- California Research Inst.
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Newport Beach, California, Forenede Stater, 82663
- Hoag Memorial Hospital Presbyterian
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Palo Alto, California, Forenede Stater, 94304
- Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
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Santa Monica, California, Forenede Stater, 90404
- Providence Health System - Southern California
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Torrance, California, Forenede Stater, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Florida
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Miami, Florida, Forenede Stater, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Forenede Stater, 33146
- University of Miami
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
- Fort Wayne Medical Oncology Hematology
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas
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Maine
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South Portland, Maine, Forenede Stater, 04106
- Maine Health
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins / Sidney Kimmel Cancer Center
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Frederick, Maryland, Forenede Stater, 21702
- Frederick Health-James M Stockman Cancer Institute
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts / Neely Cancer Center
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Michigan
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Farmington Hills, Michigan, Forenede Stater, 48334
- Detroit Clinical Research Center
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Lansing, Michigan, Forenede Stater, 48912
- Sparrow Cancer Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89169
- Nevada Cancer Research Foundation
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New York
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Buffalo, New York, Forenede Stater, 14210
- Great Lakes Cancer Center
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Children's Cancer Center
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North Carolina
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Greenville, North Carolina, Forenede Stater, 27834
- East Carolina University / Vidant Health
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Ohio
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Youngstown, Ohio, Forenede Stater, 44501
- Mercy Health Youngstown
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny Health Network
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical Univ. of South Carolina
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern Medical Center / Children's Health
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Houston, Texas, Forenede Stater, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Univ. of Utah / Huntsman Cancer Center
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Seattle Children's
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University
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Wisconsin
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La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Health System
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Madison, Wisconsin, Forenede Stater, 53717
- SSM Health Cancer Center - Dean Medical Group
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Many Locations, Frankrig
- Many Locations
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Many Locations, Italien
- Many Locations
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Many Locations, Kina
- Many Locations
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Many Locations, Luxembourg
- Many Locations
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Many Locations, Schweiz
- Many Locations
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Many Locations, Spanien
- Many Locations
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Many Locations, Sverige
- Many Locations
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Many Locations, Sydkorea
- Many Locations
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Many Locations, Tyskland
- Many Locations
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Many Locations, Østrig
- Many Locations
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adult and pediatric (from birth to 18-year-old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made before enrollment
Beskrivelse
Inclusion Criteria:
- Adult and pediatric (from birth to 18-year-old) patients
- Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
- Life expectancy of at least 3 months based on clinical judgement
- Decision to treat with larotrectinib made by the treating physician prior to study enrollment
- Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
- Signed informed consent form
- For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required
Exclusion Criteria:
- Any contraindications as listed in the local approved product information
- Pregnancy
- Participation in an investigational program with interventions outside of routine clinical practice
- Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
- Patients with NTRK gene amplification or NTRK point mutation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
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GI
adult patients with gastrointestinal (GI) cancer |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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H&N
adult patients with head and neck (H&N) cancer |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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STS
adult patients with soft tissue sarcoma (STS) |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
|
CNS
adult patients with primary central nervous system (CNS) cancer |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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Lung
adult patients with lung cancer |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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Melanoma
adult patients with melanoma |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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Pediatric
all pediatric patients regardless of tumor type will be enrolled under this cohort |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
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other
patients with other tumor types |
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
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Antal deltagere med behandlingsudløste bivirkninger (TEAE'er)
Tidsramme: Op til 30 dage efter sidste dosis
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Op til 30 dage efter sidste dosis
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Sværhedsgraden af TEAE'er
Tidsramme: Op til 30 dage efter sidste dosis
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Op til 30 dage efter sidste dosis
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TEAEs alvor
Tidsramme: Op til 30 dage efter sidste dosis
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Op til 30 dage efter sidste dosis
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Kausalitet af TEAE'er
Tidsramme: Op til 30 dage efter sidste dosis
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Op til 30 dage efter sidste dosis
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Foranstaltninger i forbindelse med larotrectinib-behandling
Tidsramme: Op til 30 dage efter sidste dosis
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Op til 30 dage efter sidste dosis
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Rimelig årsagssammenhæng mellem larotrectinib og en AE
Tidsramme: Op til 30 dage efter sidste dosis
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Op til 30 dage efter sidste dosis
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Objektiv svarprocent (ORR)
Tidsramme: Op til 8 år
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Op til 8 år
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Disease Control Rate (DCR)
Tidsramme: Op til 8 år
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Op til 8 år
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Varighed af svar (DOR)
Tidsramme: Op til 8 år
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Op til 8 år
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Tid til svar (TTR)
Tidsramme: Op til 8 år
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Op til 8 år
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Progressionsfri overlevelse (PFS)
Tidsramme: Op til 8 år
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Op til 8 år
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Samlet overlevelse (OS)
Tidsramme: Op til 8 år
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Op til 8 år
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Samlet dosis
Tidsramme: Op til 8 år
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Op til 8 år
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Start- og slutdosis
Tidsramme: Op til 8 år
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Op til 8 år
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Dosisændring under behandlingen
Tidsramme: Op til 8 år
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Op til 8 år
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Behandlingens varighed (DOT)
Tidsramme: Op til 8 år
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Op til 8 år
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ORR efter patientundergruppe(r)
Tidsramme: Op til 8 år
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Op til 8 år
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DCR efter patientundergruppe(r)
Tidsramme: Op til 8 år
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Op til 8 år
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DOR efter patientundergruppe(r)
Tidsramme: Op til 8 år
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Op til 8 år
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TTR efter patientundergruppe(r)
Tidsramme: Op til 8 år
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Op til 8 år
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PFS efter patientundergruppe(r)
Tidsramme: Op til 8 år
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Op til 8 år
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OS efter patientundergruppe(r)
Tidsramme: Op til 8 år
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Op til 8 år
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Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Tidsramme: Up to 8 years
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for all patients |
Up to 8 years
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Number of patients with abnormal developmental milestones
Tidsramme: Up to 8 years
|
Pediatric cohort only |
Up to 8 years
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Number of patients with abnormal Tanner stage
Tidsramme: Up to 8 years
|
Pediatric cohort only |
Up to 8 years
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 20324
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .